Background: The Bigfoot Unity® Diabetes Management System (System) is a smart pen cap system incorporating data from the Abbott FreeStyle Libre 2 Sensor, real-time alerts, and clinician-directed dose recommendations. The objective was to analyze real world 12-month data for a large MDI cohort using the System.
Methods: A retrospective analysis was performed using a prespecified analysis plan and de-identified data for those using the System ≥50% of time in the 90 days prior to the 12 month period with ≥45 CGM or BGM glucose readings and a baseline A1C, obtained from clinic medical records, was required (N=303). Using these same criteria, a safety cohort also included those using the System in the 90 days prior to 3 or 6 months (N=402).
Results: The mean age was 63.7 years and 86.5% had T2D. Mean baseline A1C was 8.8±1.8%. Mean GMI at the 12-month endpoint was 7.5±0.9%. Using post-market surveillance data of medical device reports to FDA, 5 severe hypoglycemia events, 1 serious hypoglycemia, 1 DKA and 1 other severe hyperglycemic event occurred and were not related to System malfunction; 4 malfunctions occurred without a reported adverse event.
Conclusions: For this 12-month cohort, primarily adults with insulin-requiring T2D using MDI with suboptimal glycemic control, System use for 12 months results in glycemic improvement. Considering the older age, results demonstrate close progression near established glycemic targets.
J. Tillman: Employee; Abbott. B.P. Olson: Employee; Abbott, Bigfoot Biomedical, Inc. J.K. Malone: Employee; Bigfoot Biomedical, Inc., Abbott.
Abbott
